System and method for providing treatment feedback for a thermal treatment device

ABSTRACT

A system and method for providing treatment feedback for a thermal treatment device ( 100 ) is provided. In certain embodiments, a thermal transmitter ( 120 ) is configured to apply an amount of thermal energy ( 104 ) to a target site ( 106 ), the thermal energy having a selected frequency and a selected power level for penetration to a depth beneath the surface of the skin. A thermal imager ( 140 ) is also provided, the thermal imager ( 140 ) being configured to capture thermal data and thermal images of the target site. The device may further provide a thermal display ( 160 ) configured to display the thermal images and thermal data, providing feedback to a user ( 201 ).

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a divisional of U.S. application Ser. No.14/510,047, filed Oct. 8, 2014, which is a continuation-in-part of U.S.application Ser. No. 14/245,973, filed Apr. 4, 2014, now abandoned, anda continuation-in-part of PCT International Application No.PCT/US14/33026, filed Apr. 4, 2014. U.S. application Ser. No. 14/245,973and PCT International Application No. PCT/US14/33026 each claim thebenefit of U.S. Provisional Patent Application No. 61/809,544, filedApr. 8, 2013, and U.S. Provisional Patent Application No. 61/836,925,filed Jun. 19, 2013. Each of the aforementioned applications isincorporated by reference herein in its entirety, and each is herebyexpressly made a part of this specification.

BACKGROUND

1. Technological Field

This application relates generally to a thermal treatment deviceconfigured to administer heat for medical treatment. More particularly,this disclosure relates to a device for applying thermal energy to atarget, monitoring the application of the via thermal energy imager on adisplay, and using the imagery to direct further application of energy.

2. Description of the Related Art

Thermal application devices may be used for heating the skin to initiateneocollagenesis, and skin tightening. Such devices may also be adaptedto provide heat in the subcutaneous region so as to burn lipids. Suchdevices may be accomplished by targeting the desired area of treatmentwith heat in the form of a radio frequency (“RF”) emitter. Use of aradio frequency allows heat energy to be applied at a desired depthbelow the surface of the skin (epidermis).

Therefore it would be advantageous to provide a system configured toapply thermal energy to a treatment area that provides timely feedbackdata regarding the treated area for subsequent application of energy.

SUMMARY

In a first aspect (for example independently combinable with any of theaspects or embodiments identified herein), a thermal treatment system isprovided, comprising: a thermal transmitter configured to apply anamount of thermal energy to a target site, the thermal energy having aselected frequency or wavelength, a selected power level, and adirection. The system may further comprise a thermal imager configuredto capture thermal data and thermal images of the target site. Thesystem may further comprise a thermal display configured to display thethermal data and the thermal images.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise a user interfaceallowing a selection of a routine for the application of thermaltreatment to the target site, the routine comprising instructions forthe application of the thermal energy, at least one processor configuredto process the thermal images and thermal data according to the selectedroutine, and a controller configured to indicate on the display arequired adjustment to the selected frequency or wavelength and theselected power level of the thermal transmitter, or command anadjustment to the selected frequency or wavelength and the selectedpower level of the thermal transmitter, based on the thermal data andthe thermal images, according to the selected routine.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise a radio frequencytransmitter configured to transmit the thermal energy to the target siteat a depth below the surface of the skin and a mechanical driveconfigured to receive commands from a controller to adjust the directionof the applied thermal energy.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise an infraredtransmitter configured to transmit the thermal energy to the target siteat a depth below the surface of the skin and a mechanical driveconfigured to receive commands from a controller to adjust the directionof the applied thermal energy.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise a memory configuredto store information related to the execution of the selected routine,the memory being accessible by the processor, the thermal transmitter,and the thermal imager, and the memory further comprising at least onedatabase for storing a plurality of routines.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise a wirelesscommunication link operationally connecting the thermal transmitter, thethermal imager, and the thermal display.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the display may be configured to display the thermalimages and a gradient map, the gradient map being configured to depict aplurality of temperatures of the tissue at the target site, at aselected depth below the surface of the skin.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the thermal imager may be configured to providethermal data at a position in the tissue anywhere in the range from thesurface of the skin to 15,000 micrometers below the surface of the skin.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the system may further comprise the thermaltransmitter may be further configured to transmit thermal energy to aselected depth anywhere in the range of zero to 15,000 micrometers belowthe surface of the skin at the target site.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the thermal transmitter may be further configured toheat the tissue beneath the target site to a temperature anywhere in therange from 35 degrees Celsius to 50 degrees Celsius.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the thermal transmitter, the thermal imager, and thethermal display may be configured in a unitary handheld unit.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the unitary handheld unit may comprise a linkpowering the unitary handheld unit; the link may be further configuredto provide communication with at least one external processor.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the thermal transmitter may be further configured tocryogenically cool the tissue at the target site to a temperature rangeanywhere from 10 degrees Celsius to negative 20 degrees Celsius.

In an embodiment of the first aspect, which is generally applicable (forexample, independently combinable with any of the aspects or embodimentsidentified herein), the thermal display may be configured to display atleast one of: the thermal images, the thermal data, and the gradientmap, the gradient map indicating graphical depiction of the temperaturesof the tissue at the target site at the selected depth.

In a generally applicable second aspect (for example independentlycombinable with any of the aspects or embodiments identified herein), amethod is provided for applying thermal treatment, comprising, providinga target site on a patient, the target site comprising tissue havingcertain characteristics, positioning a thermal transmitter, the thermaltransmitter configured to transmit thermal energy toward the targetsite, applying the thermal energy to the target site according to athermal treatment routine, the thermal energy having a selectedfrequency or wavelength, a selected power level, and a direction,capturing thermal data and thermal images of the target site with athermal imager, the thermal data and thermal images corresponding to atissue temperature at the target site, and displaying the thermal dataand the thermal image of the target site on a thermal display.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the method may, further comprise,selecting the thermal treatment routine according to thecharacteristics, monitoring the thermal images and the thermal data foran optimum tissue temperature, and adjusting the selected frequency orwavelength, the selected power level, or the direction, according to themonitoring and the selected routine.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the method may, further comprise,applying the thermal energy to the tissue at the target site at a depthbeneath the surface of the skin.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the method may further comprise storinginformation related to the execution of the selected routine in a memoryaccessible by the processor, the thermal transmitter, and the thermalimager, the memory further comprising at least one database for storinga plurality of routines.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the method may further comprise,wirelessly communicating the thermal data and the thermal images fromthe thermal imager to the thermal display; and wirelessly communicatinga plurality of control signals from a controller to the thermaltransmitter and the thermal imager.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the method may further comprise,displaying the thermal data and the thermal images on a gradient map,the gradient map configured to depict a plurality of temperatures of thetissue at the target site the a selected depth beneath the surface ofthe skin.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the thermal imager may be configured toprovide thermal data at a position within the tissue anywhere in a rangefrom a surface of the skin to 15,000 micrometers below the surface ofthe skin.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the thermal transmitter may be configuredto transmit thermal energy to a selected depth anywhere in a range froma surface of the skin to 15,000 micrometers below the surface of theskin at the target site.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the thermal transmitter may be furtherconfigured to heat the tissue at the target site to a temperatureanywhere in a range of from 35 degrees Celsius to 50 degrees Celsius.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the thermal transmitter may be furtherconfigured to cryogenically cool the tissue at the target site to atemperature anywhere in a range of from 10 degrees Celsius to negative20 degrees Celsius.

In an embodiment of the second aspect, which is generally applicable(for example, independently combinable with any of the aspects orembodiments identified herein) the thermal display may be configured todisplay at least one of the thermal images, the thermal data, and thegradient map, the gradient map indicating graphical depiction of thetemperatures of the tissue at the target site at the selected depth

In a generally applicable third aspect (for example independentlycombinable with any of the aspects or embodiments identified herein), anapparatus is provided for thermal treatment comprising, means forselecting a thermal heating routine, means for heating a target site,means for sensing thermal emittance of the target site, means forproviding feedback to a user, and means for adjusting the application ofthe thermal energy according to the feedback and the thermal heatingroutine.

In a generally applicable fourth aspect (for example independentlycombinable with any of the aspects or embodiments identified herein), anon-transitory, computer readable medium is provided, that when executedby a processor is configured to, position a thermal transmitter, thethermal transmitter configured to transmit thermal energy toward aselected target site on a patient, apply the thermal energy to thetarget site according to a thermal treatment routine, the thermal energyhaving a selected frequency, a selected power level, and a direction,capture thermal data and thermal images of the target site with athermal imager, the thermal data and thermal images corresponding to askin temperature at the target site, display the thermal data and thethermal image of the target site on a thermal display, and adjust atleast one of the selected frequency, the selected power level, and thedirection, according the thermal treatment routine.

In a generally applicable fifth aspect (for example independentlycombinable with any of the aspects or embodiments identified herein), amethod for applying thermal treatment, comprising is provided accordingto the figures and steps disclosed herein.

In a generally applicable sixth aspect (for example independentlycombinable with any of the aspects or embodiments identified herein), anapparatus method for applying thermal treatment, comprising is provided,according to the figures and characteristics disclosed herein.

Any of the features of an embodiment of the first through sixth aspectsis applicable to all aspects and embodiments identified herein.Moreover, any of the features of an embodiment of the first throughsixth aspects is independently combinable, partly or wholly with otherembodiments described herein in any way, for example, one, two, or threeor more embodiments may be combinable in whole or in part. Further, anyof the features of an embodiment of the first through third aspects maybe made optional to other aspects or embodiments. Any aspect orembodiment of a method can be performed by a system or apparatus ofanother aspect or embodiment, and any aspect or embodiment of a systemcan be configured to perform a method of another aspect or embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly some embodiments in accordance with the disclosure and are,therefore, not to be considered limiting of its scope, the disclosurewill be described with additional specificity and detail through use ofthe accompanying drawings.

FIG. 1 is a functional block diagram of a system for application oftherapeutic thermal energy according to the disclosure;

FIG. 2 is a functional block diagram of a device for application oftherapeutic thermal energy according to the disclosure;

FIG. 3 is a close up functional block diagram of the device of FIG. 2,according to the disclosure;

FIG. 4 is a functional block diagram of a user interface, according tothe disclosure.

FIG. 5 is functional block diagram of a thermal display according to thedisclosure; and

FIG. 6 is a flowchart depicting a thermal feedback process according tothe disclosure;

FIG. 7A depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7B depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7C depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7D depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7E depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7F depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7G depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7H depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7I depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7J depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7K depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7L depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7M depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7N depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7O depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7P depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7Q depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7R depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7S depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure;

FIG. 7T depicts readings of a thermal imager that implemented to providefeedback, according to some embodiments of the present disclosure; and.

FIG. 8 depicts a functional block diagram of an embodiment of thethermal treatment device according to the disclosure.

FIG. 9 depicts a bed or pod adaptable for administering thermaltreatment according to the disclosure.

FIG. 10 depicts a commercial tanning bed adaptable to deliver thermaltreatment as in the various embodiments.

FIG. 11 depicts a commercial tanning bed adaptable to deliver thermaltreatment as in the various embodiments.

FIG. 12 depicts a commercial tanning booth adaptable to deliver thermaltreatment as in the various embodiments.

FIG. 13 depicts a commercial facial tanning device adaptable to deliverthermal treatment as in the various embodiments.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description and drawings are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presented here.It will be readily understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in thefigures, may be arranged, substituted, combined, and designed in a widevariety of different configurations, all of which are explicitlycontemplated and made a part of this disclosure.

The application of thermal energy to a patient's skin for medical ortherapeutic reasons can have positive effects. Certain thermal energyapplication systems may be able harnesses these beneficial propertiesthrough the use of RF energy, microwave energy, direct heating(convective, conductive) systems, ultrasound, light (for example,proton) energy, and certain lasers system, among others. For purposes ofthis disclosure, RF will refer to the frequencies falling between 3hertz (Hz) and 300 gigahertz (GHz), while overlapping with microwaveradiation in the range of 300 megahertz (Mhz) to 300 GHz.

Medical uses of RF are based on an oscillating electrical currentforcing collisions between charged molecules and ions that aretransformed into heat experienced at the target space. RF heating occursirrespective of chromophore (color of the molecule) or skin type and isnot dependent on selective photothermolysis. RF energy can be deliveredusing monopolar, bipolar, and unipolar devices, and each RF deliverymethod has theoretical limits regarding the depth of skin penetration.

RF thermal stimulation is believed to result in a microinflammatoryprocess that promotes new collagen, tightening the skin at a targetsite. By manipulating skin cooling, RF can also be used for heating andreduction of fat. RF-based devices may further be configured tononinvasively achieve skin tightening and body contouring.

RF energy may be imparted to and/or incident on the skin, manifesting asheat within the targeted areas including depths within the skin.Application depth and area may be dependent upon the intensity of theenergy source, and the frequency and wavelength of the energy waves.These systems may be employed in medical or therapeutic environments toprovide aesthetic results by melting subcutaneous (for example, belowthe skin) fat and tightening skin, for a more youthful appearance.

Certain thermal treatment systems may further incorporate infrared (IR)energy emissions in the near-, mid-, or far-IR bands. Infrared light(also referred to herein as IR energy) is electromagnetic radiation withlonger wavelengths than those of visible light, extending from thenominal red edge of the visible spectrum at 700 nanometers (nm) to 1 mm.This range of wavelengths corresponds to a frequency range ofapproximately 430 terahertz (THz) down to 300 GHz. IR energy may beapplied to a target through the use of heating elements (metallic orceramic heating elements) or IR light emitting diode (LED) directed atthe target. IR energy may be used both as a heat source, but also as away to monitor the amount of thermal energy applied to a target, asdiscussed below. Most of the heat, or thermal radiation, emitted byobjects, is also detectable as infrared energy. This detectable energymay be captured and represented as thermal imagery.

Some thermal therapy systems may emit a constant, or steady flow ofenergy, while others implement a system using periodic bursts of energyto heat the skin and/or areas below the surface of the skin to achievethe desired effects. Other disclosed systems may utilize a hybrid havinga mix of the peaks or bursts of energy and steady energy emissions,having a custom or user-programmable profile emitting energy atdifferent times and different areas of the body. For example, atreatment procedure on the face will encounter generally thinner skinthan a procedure on the abdomen; accordingly, penetration depth of theRF energy should generally be shallower on the face than the abdomen.

Certain thermal treatment systems or devices provide a self-containedapparatus that an individual may implement. Alternatively, a clinicianmay apply the thermal energy for a specific medical process orprocedure. Some systems may control thermal energy flow through ameasurement of total energy emitted from the device or through the useof feedback controls such as a temperature sensor adjacent to or incontact with the skin, or on the output of the thermal applicationdevice, or through the use of thermal imaging.

Certain embodiments may have an indicator projected onto the skin,indicating an area of the skin where energy is applied. In anembodiment, a laser pointer or a light emitting diode (LED) may beimplemented within the device providing a sight or indicator to the userfor directing the application of the energy. Certain embodiments mayfurther comprise a measurement of how much energy is being emitted bythe system and directed toward the skin.

Certain embodiments may further have a thermal imaging system providinga qualitative or quantitative indication of how much energy is beingabsorbed by the skin. As the energy (for example, RF, heat, light(including for example, laser, LED), microwave, ultrasonic) is directedtoward the skin, the frequency and wavelength of the energy may affectthe amount of energy actually absorbed and at what depth beneath thesurface of the skin. A thermal camera implemented as a feedback systemmay provide a color gradient indicating the area of the skin heated bythe system. Such qualitative feedback may be used to show the parts ofthe skin that have been heated as indicated by the colored gradient (forexample, red for higher heat, yellow or orange for medium heat) ensuringthe user can apply the energy and heat the skin in a desired manner.Certain other embodiments may correlate the colored gradient to specifictemperatures or temperature ranges, giving a quantitative output to theuser or precise feedback to the system, allowing a more preciseapplication of energy to the skin.

Certain embodiments may further provide an indication of specifictemperatures at different levels beneath the skin. While the thermaltransmitter may be calibrated in frequency and wavelength to targetenergy to a specific layer of skin or adipose tissue (superficial skinto 15,000 μm or more beneath the surface, e.g., down to 14,000, 13,000,12,000, 11,000, 10,000, 9,000, 8,000, 7,000, 6,000, 5,000, 4,000, 3,000,2,000, 1,000, 750, 500, or 250 μm), the thermal imager may further beconfigured to detect local temperatures at a specific level beneath theskin, providing the system and the user with specific feedback as towhere the energy should be directed. This information may be provided tothe thermal display.

In certain embodiments, a processor may be implemented in the systemthat may process the feedback provided by the thermal camera fordirecting the user's application of energy. The directions provided bythe processor may be in accordance with a specific program ortherapeutic process. A thermal display may be used to direct theapplication of energy, while also providing feedback regarding theenergy already applied. The processor may direct the user where to applythe energy according to the program selected.

In certain embodiments, the system may further comprise additionalprocessor(s) automatically analyzing the thermal image feedback. Such anembodiment may comprise a thermal transmitter, a thermal imager, and oneor more processors that autonomously direct the application of theenergy without user input.

FIG. 1 depicts a system 100 for administering thermal treatmentaccording to the disclosure. As shown, a patient 102 is receivingtherapeutic RF energy 104 at a target site 106. The system 100administers and controls the emission and measurement of the RF energy104. While referred to herein as “RF energy,” the energy 104 may also beimplemented in the IR or microwave ranges. In certain embodiments, theIR and/or microwave transmissions may complement the RF transmissions,optimizing the energy absorption by the skin at the target site 102.

In an embodiment, the system 100 comprises a thermal transmitter 120, athermal imager 140, and a thermal display 160. The thermal transmitter120, the thermal imager 140, and the thermal display 160 are shownlocated remotely from each other, however as shown below, the variouscomponents of system 100 may be collocated in a fewer components,comprising two or more of the listed elements (for example, the thermaltransmitter 120, the thermal imager 140, and the thermal display 160),or in a unitary embodiment as shown below. Each of the components, thethermal transmitter 120, the thermal imager 140, and the thermal display160 are depicted as functional block diagrams with each blockrepresenting a portion of the internal electronics of each component asdescribed.

The thermal transmitter 120 may be a handheld device, as shown below inFIG. 2 and FIG. 3, or be constructed on an autonomous orcomputer-driven, motorized mount. In some embodiments, the thermaltransmitter 120 comprises a processor 122 (also referred to herein as a“CPU”) operationally coupled to a memory (“mem.”) 124 configured tostore executable programs, operating systems, or certain data requiredfor operation of the thermal transmitter 120. The thermal transmitter120 may further comprise a controller (“contr.”) 126 operationallycoupled to the processor 122 and the memory 124 and configured tocontrol the operations of the thermal transmitter 120. The thermaltransmitter 120 may further comprise an RF transmitter 128 coupled to atleast the processor 122 and the controller 106. The RF transmitter 128may be configured to transmit RF energy 104 directed to a target site106 on the skin of a patient 102 as disclosed herein. In anotherembodiment, the RF transmitter 128 may be alternatively configured as anIR transmitter. In another embodiment, both the thermal transmitter 120may be configured with the RF transmitter 128 and an IR transmitter.

In an embodiment, the thermal transmitter 126 may further comprise amechanical drive 130, operationally coupled to the controller 126. Themechanical drive 130 may be employed to autonomously move the thermaltransmitter 120 using feedback from one or more CPU 122 or user inputvia a user interface, described below. In an embodiment, the mechanicaldrive 130 may be optional if the system 100 is employed as a handhelddevice, as discussed with respect to FIG. 2.

The processor 122 may be further configured to receive input from othercomponents (for example, the thermal imager 140 and the thermal display160), analyze the input, and provide commands to the controller 126 toadjust the frequency, wavelength, and/or power level of the emitted RFenergy 104 from RF transmitter 128. In an embodiment, the thermal imager140 may receive thermal information, comprising thermal images of thetarget site 106 discussed below, as feedback and control informationthat the thermal transmitter 120 may use to adjust RF emissions 104.

The thermal transmitter 120 may further comprise a communicationscontroller (“comm.”) 132 operationally coupled to the processor 122configured to transmit and receive information and commands from thethermal imager 140 and/or the thermal display 160 via a communicationlink 110. The communications controller 132 may communicate with theanalogous communications controllers (discussed below) on the thermalimager 140 and the thermal display 160. The processor 122 may receivethermal or other sensory information from the thermal imager 120 via thecommunication link 110 and be further configured to process the sensoryinformation and adjust the emitted RF energy 104, as required by aselected routine (discussed below) or by direct user input.

A communication link 110 may be implemented as a wireless connection oras a wired connection between the various components of system 100. Inan embodiment, the communication link 110 may comprise a wireless (forexample, Wi-Fi) network. The communication links 110 implemented as awireless connection may comprise a Wi-Fi™ or Bluetooth™ transceiver orother suitable wireless communication protocols.

The thermal transmitter 120, and more specifically, the RF transmitter128, may be configured to administer thermal energy in the RF spectrumdirected at a target site 106 on the skin of a patient 102. The thermalenergy may be adjusted to penetrate to a desired depth within the skinof the patient 102. Such RF energy 104 may be referred to as “thermalenergy” herein based on the localized heating that results from theimpact of the charged RF particles on the target molecules within theskin, as noted above.

The type of energy type, frequency, and wavelength of the emissions fromRF transmitter 128 may be varied according to the type or intensity oftherapy desired. In an embodiment, the thermal transmitter 120 mayoperate in an RF/microwave range at approximately 3 Hz nm-300 GHz,outside of the visible light spectrum, but above that of IR (1 mm-10⁴Km). Certain other embodiments the thermal transmitter may furthercomprise laser or ultrasound transmitters (in addition to or in place ofthe RF transmitter 128) for the introduction of heat energy below thesurface of the skin. The frequency and wavelength of the imparted energymay be optimized such that it is absorbed at specific depths of skinwithout extreme superficial heating that may cause discomfort or burns.

In an embodiment, the thermal transmitter 120 is configured toadminister heat the target site 106 to a temperature in the range of 38°Celsius and 42° Celsius. In some embodiments, the thermal transmitter120 is configured to administer heat the target site 106 to atemperature of about 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60,61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 75, 80, 85, 90, or 95° Celsiusor higher, preferably from about 35 to about 50° Celsius, or from about40 to about 50° Celsius, or from about 45 to about 50° Celsius, or anynumber or range therebetween. In some embodiments, the skin may beheated for about 0.1 minute or less, or 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,0.8, 0.9, 1.0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17,18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 minutes or more orany number or ranger therebetween, e.g., from about 0.1 minute to 15minutes, or from about 1 minute to about 10 minutes. In certainembodiments, the skin may be heated to 47° Celsius for certainapplications for as long as ten minutes to achieve optimum results. Incertain embodiments, heating energy should be applied to skin to heatthe skin to 37° Celsius for seven minutes for optimum results forcertain lipolysis treatments. The amount of heat administered may beadjusted by reducing or increasing the rate at which the heat isemitted, or increasing the energy of the transmission.

In an embodiment, the use of the RF energy 104 may allow the clinicianto heat the target site 106 from a distance (remotely, for example)without actually contacting the skin. However, while FIG. 1 depicts athermal transmitter 120 not in contact with the target site 106, certainembodiments may contact the skin at the target site 106 as required. Inanother embodiment, at least a portion the thermal transmitter maycontact the skin at the target site 106, as shown in FIG. 7A-FIG. 7T. Inan embodiment providing contact between the thermal transmitter 120 andthe target site 106, certain sensors (not shown) may be collocated withthe thermal transmitter 120. Such sensors may further comprise athermistor or thermometer to sense local skin temperature (degrees). Thethermal transmitter 120 may further comprise a plurality of electrodesconfigured to sense skin impedance (ohms) and in order to furtherregulate the application of energy 104.

The thermal treatment selected for use with the systems and devicesdisclosed herein may further consider lipolysis that occurs at coldertemperatures as well. Cryolipolysis may occur from temperatures rangingfrom +10° C. down to −20° C. where frostbite occurs. In an embodiment,the colder temperatures targeted by the thermal treatment system 100 maybe from +10° C. to −15° C., as needed, or from +10° C. to −10 ° C., orfrom +10° C. to −5° C., or from +10° C. to 0° C., or from 0° C. to −15°C., or from 0° C. to −10° C., or from 0° C. to −5° C. In such anembodiment, the thermal transmitter 120 may be fitted with coolingelements (not shown) that may contact the skin at the target site 106.The cooling elements may be serve to prevent patient 102 discomfort orsuperficial burns at the target site 106 during energy 104 application.

In certain embodiments, cryogenic cooling elements may further beimplemented in system 100. Tissue response to cryo-cooling and lipolysisat the target site 106 may be similar to other types of heat energy (RF,IR energy 194, for example). This is discussed further below withrespect to FIG. 2.

In certain embodiments, the thermal imager 140 is configured to detectthermal energy in the infrared (IR) spectrum as a measure of the amountof energy applied to the skin at target site 106. As noted above, as thetarget site 106 absorbs energy 104, the surrounding tissue will increasein temperature. As the target site 106 increases in temperature, heat isradiated and manifests as IR energy, emitted from the target site 106and detectable by the thermal imager 140. For purposes of thisdisclosure, IR will be considered light below the wavelength of thevisible spectrum in the range of 700 nm-1 mm, or frequencies between 430THz-300 GHz. According to the ISO (International Organization forStandardization) 20473 scheme the terms “near IR” (0.78 μm-3 μm),“mid-IR,” (3 μm-50 μm), and “far IR” (50 μm-1 mm) may also be referencedherein. However, other common sub-divisions of near, mid, and far IRspectra vary and may be further sub-divided, and will be specificallyreferenced where stated.

The thermal imager 140 may comprise a processor (“CPU”) 142 configuredto execute a software program stored within a memory (“mem.”) 144. Thethermal imager 140 may further comprise at least one controller(“contr.”) 146 operationally coupled to the processor 142 and memory144. The thermal imager 140 may further comprise an imaging sensor(“IR”) 150 operationally coupled to at least the controller 146 andconfigured to capture thermal images of the target site 106 andcommunicate the thermal images to the processor 142 and memory 144 forstorage. The thermal transmitter 140 may further comprise acommunications controller 152 operationally coupled to the controller146, and configured to communicate with the analogous communicationscomponents of the thermal treatment system 100, for example,communication controller 132 of thermal transmitter 120.

The thermal imager 140 may further comprise an imaging sensor 150operationally coupled to at least the processor 142. The imaging sensor150 may be formed at least in part using germanium (“Ge”) lenses. Gelenses appear opaque and reflective to visible light. Ge lenses,however, may be useful in implementations for IR filtration and sensingas many Ge compound are transparent to IR light/energy. The imaginingsensor 150 may be configured to sense thermal emissions from the targetsite 106, as discussed below. The thermal images provided to theclinician administering the thermal treatment to the patient 102 may usethe thermal images as feedback, indicating where energy 104 has beenapplied and where energy 104 need be applied next.

In an embodiment, the thermal imager 140 may further comprise amechanical drive 154 operationally coupled to the controller 142. Incertain embodiments, the thermal imager 140 may be mounted to anautonomous system configured to adjust a field of view of an imagingsensor 150.

The imaging sensor 150 may be configured to provide precise thermalreadings of the target site 106. The thermal imager 140 may be furtherconfigured to provide a high-resolution thermal reading of the targetsite 106 at multiple depths beneath the skin. The memory 144 may storevarious programs and/or algorithms that when executed by the processor142, are configured to calculate precise measurements of the temperatureof various areas at various depths below the skin surface at the targetsite 106. The controller 146 may use the information from the processor142 regarding the detected thermal images (FIG. 7A-FIG. 7T) to generatecommands communicated to the thermal transmitter 120 via communicationlink 110. These commands function as precise and timely feedback,comprising a directional adjustment or transmission level adjustmentcommand to the thermal transmitter, based on the thermal imagery of thetarget site 106. In certain embodiments, the feedback provided by thethermal imager 140 is nearly instantaneous, providing optimuminformation for completion of the medical procedure.

The thermal imager 140, and more precisely, the communication controller152, may transmit data regarding the thermal imagery to a communicationcontroller 172 integrated into the thermal display 160, viacommunication link 110. In an embodiment, the communication link 110 mayallow communication with, and projection of the thermal images andthermal data on, multiple thermal displays 160. Accordingly, in certainembodiments, one or more of the multiple displays 160 may be locatedapart from the thermal transmitter 120 and/or the thermal imager 140.

The thermal display 160 may comprise a processor (“CPU”) 162 configuredto process the data received by the communication controller 172. Thethermal display 160 may further comprise a memory (“mem.”) 164operationally coupled to the processor 162 configured to store datarelated to data captured by the imaging sensor 150. The thermal display160 may further comprise a controller 165 operationally coupled to theprocessor 162 and memory 154 and configured to control the operations ofthe thermal display 160. The processor 162 and controller 166 may befurther configured to receive user input via a user interface 170. In anembodiment, the user interface 170 may comprise a touchscreen or display(for example, an LED display) configured to both receive input anddisplay images captured by the thermal imager 140. The user interface170 may further comprise a plurality of buttons, switches, or knobs.

In an embodiment, the user interface 170 may comprise a drop down menufor selection of a routine (described in FIG. 5) provided on the userinterface 170. The user interface 170 may further comprise a cluster ofbuttons, switches or other controls located on the thermal display 160configured to receive user input. In an embodiment, the controls may belocated on the thermal transmitter 120 or the thermal imager 140.

The processor 162 and controller 166 may further be configured send datato the user interface 170, depicted as a visual representation ofvarious temperature gradients at the targeted site 106. The userinterface 170 within the thermal display 160 may provide the operatorwith a visual representation of both the target site 106 to which RFenergy and heat is being administered as well as the surrounding area.The processor 162 may further processes the thermal reading data togenerate a gradient map 200 (shown in FIG. 4) of the target site 106 andthe area surrounding the targeted treatment area.

The processor 162 may be further configured to process the thermal imagedata to provide suggestions of additional target sites 106 or areas ontowhich the thermal transmitter 120 should focus to optimize the use ofthe RF emissions 104. The suggestions may be displayed on the userinterface 170 as a plurality of arrows (not shown) indicating to theuser where to direct the thermal transmitter 120. The arrows may lightup on the thermal display 160, and the user may process the suggestionswith the thermal image shown on the thermal display 160 to move thethermal transmitter 120.

The thermal display 160 may further include a database 174 operationallycoupled to the processor 154. The database 174 may be housed within thememory 164 or may be configured as a separate component. While FIG. 1depicts the database 160 housed within the thermal display 160, thethermal imager 140 and the thermal transmitter 120 both may have accessto the information contained within the database 174 via link 110.Although not shown here, in certain embodiments, the thermal transmitter120 or the thermal imager 140 may alternatively comprise the database174 or comprise their own individual databases 174.

The database 174 may comprise a plurality of routines containinginstructions to the system 100 to execute certain functions. Theroutines, when executed by the processor 164, may be configured tocommand movement of the thermal imager 140 (via the drive 154) to adjustfocus to a different target site 106. The routines may be designed tocommand to the thermal transmitter 120 to adjust RF emissions and applyenergy 104 to various parts of the target site 106 to optimize energy104 exposure for a certain thermal treatment or procedure. In anembodiment, such commands or routines may be input by a clinician orother user (not shown). In certain embodiments, the system 100 mayoperate autonomously once a user selects a routine.

In an embodiment, routines are selected via the user interface 170. Theuser interface 170 may comprise a drop down menu (discussed with respectto FIG. 5) provided on the thermal display 160 that may be controlled bya touch screen or a cluster of buttons. Each routine may compriseoptimum temperatures for a specific body part, which may also becross-referenced with a specific type of treatment. For instance, one ofthe routines may be directed towards fat burning in which optimum heattemperatures are provided for various depths beneath the outer surfaceof the skin. Each routine may administer RF energy 104 differently as aresult of the type of body part (target site 106) being treated. Forinstance, a routine which targets fat (adipose tissue) found along theabdominal area might run through heat treatments at layers 3,000-4,000microns (or micrometers (μm)), 4,000-5,000 μm, 5,000-6,000 μm,6,000-7,000 μm, 7,000-8,000 μm, 8,000-9,000 μm, or 9,000-10,000 μmbeneath the top surface of the skin. In an embodiment, a routine mayapply RF energy 104 to any depth of tissue between the surface of theskin down to 15,000 μm below the surface of the skin. Certain proceduresmay comprise a routine that applies energy 104 to a shallower depthbeneath the for skin rejuvenation along the face. In such an embodiment,the energy 104 may be applied at depths from the surface to 1,000,2,000, 3,000, or 4,000 μm or more (e.g., 5,000, 6,000, 7,000, 8,000,9,000, 10,000, 11,000, 12,000, 13,000, 14,000, or 15,000 μm or more)beneath the top surface of the skin.

In an embodiment, the desired thermal treatment may comprise skin ortissue tightening at layers of the skin from the epidermis through tothe reticular dermis. In another embodiment, the desired treatment maycomprise fat melting or adipolysis (adipose fat digestion) in areas withhigh concentrations of cellulite, for example. The foregoing should notbe considered an exhaustive list, as the system and devices of thedisclosure may be used on any portion of the body requiring suchtreatment.

In an embodiment, each routine may include optimum temperatures for aspecific body part, which may also be cross-referenced with a specifictype of treatment. As a non-limiting example, one of the routines may bedirected towards fat burning in which optimum heat temperatures areprovided for various depths beneath the outer surface of the skin. Eachroutine may administer heat differently as a result of the type of bodypart, which is being treated. For instance, a routine targeting fatfound along the abdominal area might run through heat treatments atlayers 4,000 μm beneath the top surface of the skin, 6,000 μm beneaththe top surface of the skin, as well as 10,000 μm beneath the topsurface of the skin, whereas a routine directed towards skinrejuvenation along the face may only target sites 4,000 μm underneaththe top surface of the skin.

The temperature range of each routine may also vary. Thus, theprocessors 122, 142, 162 may cooperate in order to optimize theapplication of thermal energy 104. In certain embodiments, theprocessors 122, 142, 162 and controllers 126, 146, 166 in coordinationwith the drives 130, 154, to command the system 100 to automaticallyadjust the RF emissions 104 to achieve the temperature a specificroutine requires.

Many thermal treatment operations require specific temperatures atspecific locations and specific depths beneath the skin. Accordingly, ahigh degree of accuracy and precision may be required in threedimensions to achieve the desired outcome. The various components of thesystem 100 may operate in conjunction, to deliver RF energy 104 to thetarget site 106, monitor the location and temperature of the target site106 using the thermal imager 140, while providing timely feedback to theapplicable controllers 126, 146, 166 to achieve appropriate adjustmentsto accomplish the desired procedure.

FIG. 2 shows an embodiment of a thermal treatment device 200 inaccordance with the disclosure, being employed by a user 201 (alsoreferred to herein as “operator” or “clinician”) on the target site 106.In an embodiment, the thermal treatment device 200 comprises a housing202, providing a mounting point for the various components of thethermal treatment device 200 and for protecting the internalelectronics. The internal electronics are depicted here as a functionalblock diagram within the housing 202. The thermal treatment device 200further comprises a thermal transmitter 220 substantially similar to thethermal transmitter 120. The thermal transmitter 220 may be configuredto transmit the energy 104 toward the target site 106 (shown in dashedlines). The thermal treatment device 200 may further comprise a thermalimager 240 substantially similar to the thermal imager 140 of FIG. 1.The thermal imager 140 may sense heat emitted from the target site 106as IR energy and provide associated thermal images and thermal data to athermal display 260, substantially similar to thermal display 160. Thethermal images displayed on the thermal display 260 may provide feedbackto the user 201 for the timely adjustment of application of RF energy104 at the target site 106, in at least direction, frequency,wavelength, and power level.

In an embodiment, the thermal display 260 is configured to provide avisual representation of readings of the thermal imager 240, providingreal-time feedback to the user 201. The thermal display 260 may bemounted to a top portion of the housing 202, providing timely feedbackto the user 201. The thermal display 260 may be further collapsible ordeployable in a direction 208. The thermal images (shown in FIG. 7A-FIG.7T) may indicate the areas that have already been heated with the RFenergy 104 as well as those areas that have not. This may allow moreprecise application of RF energy 104. Some specific examples of thethermal images are discussed below with respect to FIG. 7A-FIG. 7T.

In an embodiment, the thermal display 260 may be mounted on top of thehousing 202, as shown, or may be positioned on one of the sides of thehousing 202 as needed for specific design requirements. In anembodiment, the device 200 may not be fitted with an integral thermaldisplay 260 as shown, but it may be constructed or formed as an externaldisplay, similar to the thermal display 160 of the device 100 (FIG. 1).

The thermal treatment device 200 may further comprise a processor(“CPU”) 222 operationally coupled to a memory (“mem.”) 224. The memory224 may store code such as an operating system, required for the properoperation of the device 200. The memory 224 may further comprise datastorage for thermal images sensed by the thermal imager 240. The memorymay further comprise a database analogous to database 174 (FIG. 1)containing the routines for application of thermal energy, as discussedabove. The processor 222 may be configured to execute a routine or othersoftware program configured to provide a depth of reading for thethermal imager 240.

The device 200 may further comprise a controller (“contr.”) 226operationally coupled to the processor 222 and memory 224. In anembodiment, the processor 222 may be further configured to providesuggestions to the controller 226 of areas within the target site 106 tofocus the thermal transmitter 222 in accordance with the selectedroutine. The suggestions may comprise a plurality of arrows or otheron-screen graphics depicted on the thermal display 260 indicating to theuser 201 where to direct the application of RF energy 104. The arrowsmay light up on the thermal display 260, and the user 201 may use thesuggestions with the thermal image shown to more accurately adjustapplication of RF energy 104 from the thermal transmitter 220. Theprocessor 226 may further provide on-screen indication of an automaticadjustment of energy 104, or prompts indicating to the user 201 that amanual adjustment to the energy 104 output is required.

The processor 222 may further be configured to process the thermalreadings so as to generate a visual representation of the target site106 that directs the application of heat by the user 201. As anon-limiting example, in an embodiment the processor 222 may processesthe thermal reading to generate a gradient map (shown in FIG. 4) of thetarget site 106 and the surrounding area. The gradient map may becolor-coded and depicted specific temperatures of the area at the targetsite 106. As will be discussed below, the gradient map may depict areasthat require the application of additional energy 104 as yellow, areasthat have been sufficiently heated may be displayed in green, and areasare absorbing too much RF energy 104 may be displayed in red. Such avisual representation may be done at both the top surface of the skinand at various selected subcutaneous levels. Accordingly, as the user201 is able to see by a visual indication of the heat gradient of thedesired body part, the user 201 can direct the thermal treatment device200 to the part of the body corresponding to yellow parts of the thermaldisplay until the body part turns green, for example, on the thermaldisplay and may reduce application or back off of a treated area in theevent that it turns red on the thermal display 260.

In an embodiment, the processor 222 may use the sensory informationprovided by the thermal imager 240 to command the controller 226 toselectively actuate the thermal transmitter 220. Accordingly, thethermal treatment device 200 may automatically adjust (increase orreduce) the thermal transmitter 220 output according to the readings ofthe thermal imager 240. In an embodiment, this automatic energyreduction feature may be suitable as a safety mechanism, minimizing anexcessive application of RF energy 104 and heat, while allowing the user201 to monitor and track the thermal treatment.

In an embodiment, the controller 226 may further use information fromthe processor to command a RF transmitter (not shown in this figure, andsubstantially similar to RF transmitter 128) to adjust RF emissions 104as needed. In an embodiment, the major components of the device 200,particularly the thermal transmitter 220, the thermal imager 240, andthe thermal display 260 are substantially similar to those components inFIG. 1 providing substantially similar functions.

The feedback provided by the thermal imager 240 may be stored in thememory 204, processed by the processor 222, and output to the controller226 which may command an adjustment to the RF output of the transmitter220 in accordance with a selected routine. Advantageously, the increasedprecision of the feedback provided by the thermal imager 240 may providethe user with precise and individualized corrections, optimizing theapplication of the RF energy 104.

The device 200 may further comprise a link 250, operationally coupled tothe processor 222, the memory 224, and the controller 226. The link 250may provide a communication link to additional processors or a largercomputer system (not shown) for the storage and use of thermal images.In an embodiment, the link 250 may further allow the processor 222 toremotely store routines (for example, the database 174 of FIG. 1) oraccess the additional processors to aid in processing the thermal imagesprovided by the thermal imager 240 to provide the rapid feedback to theuser 201. In another embodiment, the link 250 may further power thedevice 200.

In certain embodiments the link 250 may further provide the thermalimages and thermal data to an external display, such as the thermaldisplay 160 (FIG. 1). In such an embodiment, the user 201 may utilizethe thermal display 260 as a feedback control, as disclosed herein,while another clinician or the patient 102 may be able to view theprocedure as RF energy 104 is being applied by the user 201.

In an embodiment, the thermal transmitter 220 is configured toadminister heating energy so that the skin is heated in a range between37° Celsius and 43° Celsius at a desired depth beneath the surface ofthe skin. The amount of heat administered to the target site 106 may beadjusted by reducing or increasing the rate at which the heat is emittedthrough changing frequency or wavelength, or by increasing the magnitudeof the transmission energy (for example, RF energy 104). In certainembodiments, the thermal transmitter 220, like the thermal transmitter120, may transmit energy 104 in the RF spectrum at any frequency orrange of frequencies between the ranges of 3 kHz to 300 GHz. In certainembodiments, the RF energy 104 may also be transmitted within themicrowave radiation range anywhere in the range of 300 Megahertz (Mhz)to 300 GHz. Such transmissions may have wavelengths from 10⁵ meters (m)to 0.1 mm, e.g., from 10⁴ meters to 1 mm, or from 10³ meters to 10 mm,or from 10² meters to 100 mm, or from 10 meters to 1 meter. Suchwavelengths may correspond to the possible frequency bands listedherein.

In certain embodiments, the energy 104 may also be IR energy, as notedabove. In an embodiment, the thermal transmitter 220 may further emitenergy 104 in the form of far IR energy, falling anywhere in wavelengthspectrum from 15 μm to 1 (one) millimeter (mm), e.g., from 10 μm to 0.5mm, or from 1 μm to 0.1 mm.

In an embodiment implementing a cooling element, as noted above in FIG.1, a reduction in temperature of tissue at the target site 106 may beaccomplished by a cooling element or elements (not shown) comprising acooling element affixed to the distal end of the thermal transmitter220. The cooling element may comprise a refrigerant- or water-cooledelement that may be in contact with the skin at the target site 106. Asupply for the cooling element may be situated external to the device200, with a link 250 configured to supply a circulating coolant throughthe portion of the thermal transmitter 220 in contact with the tissue atthe target site 106. Various illustrations of such an embodiment aredepicted in FIG. 7A-FIG. 7T. As noted previously, the cooling elementsmay provide cooling of the tissue for lipolysis/adipolysis or fortopical skin cooling at the target site 106, reducing the potential forsuperficial burns from the energy 104.

FIG. 3 shows another view of device 200, with the thermal display 260 isillustratively shown deployed, providing a gradient map 210 showing thethermal gradient of a body part (for example, the target site 106)treated by the thermal treatment device 200. Though FIG. 2 shows thethermal treatment device 200 used on the abdomen of a patient, it shouldbe appreciated that the thermal treatment device 200 may be used onother body parts as needed, such as the face, legs, neck, and arms.

The thermal treatment device 200 may both transmit thermal energy as RFemissions 104 to the target site 106 as well as map the thermal readingssensed by the thermal imager 240 at the target site 106. Thus, theoperator 201 is able to manually adjust the application of RF energy 104along the target site 106 so as to achieve a desired temperature. Insome embodiments, to accomplish a desired routine, the temperatureacross the target site 106 may need to be substantially uniform. Thethermal imagery and feedback to the user may enable a substantiallyuniform distribution of RF energy 104 and heat across the target site106.

In an embodiment, the thermal imager 240 may provide thermal readings atmultiple levels beneath the surface of the skin, displayable on thethermal display 260. By manipulating the user interface 228, the usermay display one or more of the various readings, from, for example thetemperature of the top surface of the skin (epidermis) may be provided,or the temperature of a predetermined depth of the body part at thetarget site 106 may be provided. Accordingly, the user is givenreal-time feedback with regard to achieving a desired temperature for aprocess such as lipid burning, while maintaining awareness of thetemperature of the target site and considering the patient's 102 comfortlevel and the risk of burns.

The housing 202 may further include a grip portion 214 configured to begripped for one-handed operation. An end portion of the housing 202 maybe adapted to secure the thermal transmitter 220 as shown. The thermaldisplay 260 is shown mounted to a top surface of the housing 202. In anembodiment, the thermal display 260 may be constructed on a hinge mount,allowing it to deploy or fold in the direction 208 (FIG. 2) or pivotabout a vertical axis (not shown).

The device 200 may further comprise an actuator 216. The actuator 216may be a button or a switch operationally coupled to the controller 226and configured to actuate both the thermal imager 240 and thermaltransmitter 220. The thermal imager 240 and thermal transmitter 220 maybe actuated simultaneously. In another embodiment, the device 200 mayinclude individual actuators 216 (not shown), each configured to actuatethe thermal imager 240 or thermal transmitter 220.

In an embodiment, the thermal transmitter 220 may comprise a variableactuator 217 allowing manual adjustment or tuning of the RF energy 104transmitted by the thermal transmitter 220. The variable actuator 217may adjust the frequency, wavelength, power, phase, and/or amplitude ofthe emitted RF energy 104. The functions of the variable actuator 217may be further augmented by other portions of the user interface 228,depicted in FIG. 3 as the variable actuator 217 and a series of buttons219. The actuators 216 may also be considered part of the user interface228. While the thermal transmitter 220 is illustratively describedherein as an RF emitter, certain embodiments of device 200 may beadapted to emit thermal energy in other forms such as laser, ultrasound,or the like.

The thermal treatment device 200 may further comprise a plurality oftips 230 applied over the thermal transmitter 220. Each thermal tip 230may be predesigned and optimized for applying a specific type and amountof energy to a specific depth of skin. In an embodiment, each tip 230 isconfigured to apply thermal energy at a predetermined depth from the toplayer of a patient's skin (shown in FIG. 2). As a non-limiting example,tip 230 a may provide thermal treatment at a depth of 4,000 microns (ormicrometers (μm)) beneath the top surface (epidermis) of the skin,whereas tip 230 b may be configured to provide thermal treatment at6,000 μm beneath the top surface of the skin, and tip 230 c may beconfigured to provide thermal treatment at 10,000 μm beneath the topsurface of the skin. Each tip 230 may direct the energy at a specificpattern, frequency, wavelength, or magnitude for proper application ofheating energy to the skin. In an embodiment, the device 200 maycomprise the tips 230 may operate in lieu of the actuators 216, 217. Inan embodiment, the tips 230 may operate in conjunction with theactuators 216, 217, providing some degree of adjustment within thedesign specifications of the tips 230 a.

In an embodiment, the thermal imager 240 is configured to provide ahigh-resolution thermal reading of an application area along multipledepths beneath the skin. The thermal imager 24 transmits its readings,or images, to the a processor 222 (FIG. 2) and to the thermal display260 to provide the user with a visual representation of the heatingenergy absorbed by the skin, both at the target site 106 in addition tothe surrounding area.

The device 200 is illustratively shown having tip 230 b installed, so asto administer heat at a depth of 6,000 μm underneath the surface of theskin. It should be appreciated, that the delivery of heat at that depthmay also administer heat at the layers between the top surface of theskin and the optimized depth. Further, it should be appreciated that theapplication of RF energy 104 and heat may depend upon the physicalcharacteristics of the body part (for example, target site 106) beingtreated. As a non-limiting example, a subcutaneous area covered by ascar or a birthmark may take longer to reach an optimal temperature asthe energy 104 may be absorbed by the scar or birthmark instead of theskin beneath. Accordingly, the patient 102 may feel discomfort at thesite of the birthmark, prior to achieving a desired temperature at thesubcutaneous level.

As the device 200 is actuated, the thermal transmitter 220 may applyenergy 104 and heat to the target site 106 which is simultaneouslysensed by the thermal imager 240 and mapped to the thermal display 260.The gradient map 210 may be configured to show an absolute temperatureof the skin (target site 106) at different levels beneath the surface.In an embodiment, one display setting may depict the temperature of thesurface of the skin on the thermal display 260, and in another setting,the temperature at the targeted depth of the body part may be providedon the thermal display 260.

For illustrative purposes, assume that the operator 201 (FIG. 2) hasselected a routine for controlling the actuation of the thermaltreatment device 200 as applied to the target site, for example, theabdomen as shown in FIG. 1 and FIG. 2. The processor 222 may execute aprogram to vary the reading of the thermal imager 240 at a depth of6,000 μm and at the surface of the abdomen. For illustrative purposes,6,000 μm below the surface of the skin may be the location where mostlipids are found on the patient 102. The tip 230 b is selected toprovide heat treatment at 6,000 μm below the surface of the skin.Accordingly the thermal display 260 is activated and will provide athermal image of both the top layer of the skin at the target site 106as well as the targeted depth (6,000 μm) of heat application. The usermay monitor the results of the heat treatment on the thermal display260, and may manually adjust the output of the thermal transmitter 220so as to achieve a desired temperature both at the top surface andsubsurface levels. The user may also manually direct the thermaltreatment device 200 so as to deliver energy 104 and heat to areas thathave no yet reached the desired temperature at the subcutaneous level,while simultaneously keeping heat from being administered at certain topsurfaces of the abdomen.

In another embodiment, the processor 222 may gather thermal readingsfrom the thermal imager 240 to automatically control the transmission ofthe thermal transmitter 220 so as to achieve a desired temperature atthe subcutaneous level while preventing discomfort to the patient at thetopical level.

FIG. 4 shows a diagram of the gradient map 210 (FIG. 3) displayingthermal gradients resulting from data collected by the thermal imager240, 140. As noted above, the gradient map 210 may provide a user timelyand precise feedback regarding the application of energy 104 to thetarget site 106. In an embodiment, the gradient may be color-coded. Forpurposes of this discussion, the range of temperatures less than 40° C.may be colored green 420, areas from 40° C.-42° C. are colored yellow415, areas from 41° C.-42° C. are colored orange, and areas from 42°C.-44° C. and higher may be colored red. The gradient map 210 mayfurther have a gradient key 425 indicating the temperatures asrepresented by the colors in the gradient. The gradient map 210 isintended to provide a visual indication of what areas within the targetsite 106 have achieved the optimum temperature according to a selectedroutine, and those that are not, such that the user 201 may adjust theenergy 104 as needed. It is to be appreciated that each of the colorsmay be selected based on user 201 (FIG. 2) and device 200 requirements.It should also be appreciated that the specific scale shown in FIG. 4 isa non-limiting example of temperature ranges. The scale colors andvalues may be adjusted as desired.

Accordingly, as the user 201 is able to see by a visual indication ofthe heat gradient of the desired body part or target site 106, the user201 can move the thermal transmitter 220 to the part of the bodycorresponding to the appropriate colors depicted in the gradient map210. As non-limiting example, the user 201 or clinician may concentrateenergy 104 on certain yellow parts of the gradient map 210 until thatbody part (for example, the target site) turns orange on the thermaldisplay 260 and may decrease the energy 104 in a treated area in theevent that it turns red.

In an embodiment, the colors are not limited to four distinct colors butto a constant spectrum from purple or black, for example, designating acold (for example, below 37° C.) region through the visible lightspectrum to red (for example, hot). Accordingly, a central color such asorange (as shown) or green may be selected as the color representing an“optimum” temperature for the selected routine.

In another embodiment, the absolute temperature of the target site 106may further be displayed on the gradient map, as shown, in addition tothe depth reading 430. In another embodiment, a different gradient map210 may be selected and displayed for a given skin depth 430.

FIG. 5 depicts a selection screen 400 that may be displayed on the userinterfaces 170, 228, showing several possible user-selectable routines440 a-440 e that may be chosen via the user interface 228. As shown,routine 440 a may be selected for a fat burning process on the abdomenrequiring a first energy 104 frequency (and wavelength) and depthsetting. Routine 440 b may be a fat burning process on the face possiblerequiring a less powerful routine than routine 440 a. Routine 440 c forwrinkle removal and skin tightening on the face and jaws or routine 440d for wrinkle removal around the eyes may require a lower setting stillfor a different amount of time. Routine 440 e may be directed to aprogram or routine configured to address the areas that are heated to alesser degree than others (“−less”). In the routine 440 e, the user 201may be directed to apply RF energy 104 to equalize the temperatureapplied across the target site 106 in a uniform manner. Advantageously,this may lead to an increase in the uniformity of skin heating acrossthe target site 106 and reduction of heat “cavitation,” leading toirregularities and inconsistent results. “Cavitation” as used hererefers to irregular, or non-uniform heating.

FIG. 6 shows a flowchart depicting a method 600 for providing feedbackin a thermal treatment device according to the disclosure. In anembodiment, the method 600 begins with block 602 where a target site 106on the patient 102 is provided. In an embodiment, the target site 106may be an area on the abdomen where the patient 102 desires to reducethe amount of fat present. Alternatively, the target site may be a moresensitive area (such as the eyes) where the patient 102 desires a skintightening procedure.

At block 604, a clinician 201 may position the thermal transmitter 120,220, and direct it toward the target site 106. At block 606, theclinician 201 may select and initiate a desired thermal treatmentroutine. Once the thermal treatment routine has been initiated, at block608 the thermal transmitter 120, 220 may apply RF energy 104 to thetarget site 106.

In an embodiment, at block 609, the thermal imager 140, 240 may capturethermal images of the target site 106 as RF energy 104 is absorbed bythe tissue at the target site 106 and display the thermal images on thethermal display 160, 260. The thermal imager 140, 240 may make use ofgermanium lenses or other thermal detection technologies for thedetection and capture of thermal images of the target site 106. Incertain embodiments, forward-looking infrared technology (FLIR) and CCD(charge-coupled device) cameras capable of capturing thermal images mayalso be implemented for such a purpose. The processor 142, 242 may usethe communications controller 146 to communicate the images as feedbackto the thermal display 160, 260 for processing and display on the userinterface, 170, 226 at block 610. In certain embodiments, some of theprocessing may be carried out locally within the processor 122, 142 atthe thermal imager 140, 240. In an embodiment, the processor 162 may,according to the selected routine stored within the database 174,determine that the optimum temperature has been reached at the targetsite 106. The optimum temperature may be at the surface of the skin,below the surface of the skin, or fall within a range of temperaturesaccording to the routine. If that optimum temperature is reached, atdecision block 614, the processor 162 may determine whether there isfurther tissue within the target site requiring treatment or the processrequires the optimum temperature be maintained for a particular amountof time. If the routine has completed, then the method 600 ends at block616.

At decision block 614, when the processor 162 determines there arefurther areas requiring thermal treatment, the controller 162 maycommand the thermal transmitter 120 to adjust aim at block 618 and movethe RF energy 104 to a different location. The controller 162 mayfurther command the thermal imager 140 to adjust the field of view. Inthe event the device 200 is being employed, the processor 222 maydetermine that the adjustment is required and indicate to the clinician201 on the thermal display 260 where to apply the RF energy 104 andwhether and how much the energy 104 may have to be adjusted in poweroutput and/or frequency/wavelength. The method 600 may then return toblock 608 and apply energy 104 to the target site 106 at block.

At decision block 612, if the target site 106 is not at the optimumtemperature, the processor 162 may determine if the temperature is toohot (decision block 620) or too cold (decision block 622) according tothe routine and database 174. If the target site is too hot, theprocessor 162 may determine that the aim point of the thermaltransmitter 120 needs to be moved and proceeds to block 618. The method100 may then proceed as explained above.

At decision block 622, if the target site is too cold, then theprocessor 162 may indicate that more energy 104 is required for theroutine. In an embodiment, if the clinician is using device 200, thenthe thermal imagery displayed on thermal display 260 may indicate colorsand temperatures indicating a target site 106 that is still too cold,according to the routine. The routine may then require additional energyapplied to the target site 106, as the method 600 returns to block 608and proceeds as noted above.

FIG. 7A-FIG. 7T are thermal images from a thermal treatment procedureaccording to the present disclosure. FIG. 7A shows a thermal image 710of a clinician 712 applying RF energy 104 to a patient 102 with athermal treatment device 700 (FIG. 7B), similar to that discussed above.The device 700 may be analogous to the device 100 as discussed above.FIG. 7A shows a thermal image 710 that may be representative of thethermal information displayed on thermal display 160, 260 for use by theclinician 712 or by the controllers as feedback to conduct the treatmentprocedure. The thermal image 710 depicts the absorption of thermalenergy 104 by the target site 106 with the lighter colors (white)designating the areas that have been heated. The thermal image 710 maybe further superimposed with the thermal gradient such as in thegradient map 210. The “measurements” indicated on the figurescorresponds to the temperature of the target site with in the box,“Ar1,” designating target “area” one. Subsequent figures depict multiple“Ar's” (for example, Ar1, Ar2, Ar3) that may be used to indicate variousranges within the gradient map 210. In some figures, an “El1” may beutilized for the same purpose, The various features of the gradient map210 depicted in FIG. 4 may be further added to the thermal image 710 toprovide further information and feedback to the clinician 712.

As shown in the subsequent images in FIG. 7B-FIG. 7T, the clinician 712may move the device 700 in various locations to complete the procedureor routine 440 as discussed herein. The thermal images 710 and constantfeedback from the application of the energy 104 to the patient 102 mayoptimize the procedures by providing the clinician 712 with a visual andqualitative representation of where energy 104 has been applied andwhere it has not. The “measurements” depicted in the thermal images 710of FIG. 7A-FIG. 7T further provide a quantitative indication of the skinheating allowing the clinician 712 to more accurately and efficientlydirect the thermal treatment. The “Max,” “Min,” and “Average” notationsin the “Measurements” box refer to the relative temperatures within thedesignated area Ar1, as shown, for example, in FIG. 7A. FIG. 7G depictsmultiple areas Ar1-Ar3 and the associated temperatures. An area El1,shown in FIG. 7B depicts a similar range of temperatures, indicating tothe clinician 712 various temperature measurements at the target site106.

FIG. 8 depicts a functional block diagram of an embodiment according thedisclosure, referred to as a thermal treatment device 800. The device800 comprises a means for selecting a thermal heating routine 802. Themeans for selecting a heating routine may be configured to allow a user201 to select a specific target site 106 around the abdomen or otherarea as required. The routine may provide details as to how much thermalenergy is required at the target site 106 and how to adjust theapplication of the energy 104 in response to feedback from a means forsensing the thermal emittance (discussed below).

The means for selecting the selecting a thermal heating routine 802 isoperationally coupled to means for heating a target site 804, accordingto the selected routine 440. The means for heating a target site 804 mayfurther direct energy 104 to the target site 106 according to user 201input.

The device 800 may further comprise means for sensing thermal emittance806. As energy 104 is absorbed by the target site 106, the target site106 will radiate or otherwise emit IR energy that may be captured by themeans for sensing thermal emittance 806. The means for sensing thermalemittance 806 may then feed the associated thermal information back asthermals images and specific temperatures at selected skin depths to ameans for providing feedback to a user 808. The means for providingfeedback to a user 808 may comprise a display, as noted above, depictinga gradient map indicating the portions of the target site 106 that havebeen heated. The means for providing feedback to a user 808 may furtherindicate portions of the target site 106 that require furtherapplication of energy 104, in accordance with the selected routine 440.

The device 800 may further comprise means for adjusting application ofthermal energy to the target site 810. The means for adjustingapplication of thermal energy 810 may use the feedback provided by themeans for providing feedback 808 to adjust the output of the means forheating a target site 804 in order to comply with the requirements ofthe selected routine 440.

A hand-held apparatus can be conveniently employed for administeringtreatment in certain embodiments. In other embodiments, it can beadvantageous to employ a pod, bed, booth, canopy, or other structureincluding one or more of the components of the systems as describedherein to administer treatment.

In one embodiment, the thermal treatment is administered by use of a bedor a pod similar in design to a conventional tanning bed. FIG. 9 depictsthe SUNVISION 28LE2F, a conventional tanning bed including variouscomponents: a cover or canopy, a fan, a capacitor, a ballast, acontactor or relay, wiring harness timer to remote, remote port PCB,hinge brackets, a gas spring, lamp holders, lamps, endcap, legs, timerbezel and timer, switch, face tanner, skirt kit, silk-screened profile,cover or bench, and trim profile. The bed or pod can provide coverage ofany portion of the patient's body. For example, in a bed configuration,the patient lies on the bed (e.g., face up, face down, or any otherposition), and emitters in the bed apply energy to a body part adjacentto the surface of the bed. The surface on which the patient is placed istransmissive to the radiation, e.g., holes or other ingresses providepassage therethrough for the energy, or the surface is fabricated from amaterial that is at least partially transmissive to the radiation. Inanother design, the patient lies on a bed or other surface, and a frame,canopy, or other structure incorporating one or more emitters is placedover the patient. Alternatively, a pod or booth in which the patientstands is provided, and one or more emitters arrayed in the pod or boothadminister the energy while the patient is standing. Systems employedfor application of radiation, or UV light, can be adapted to similarlyadminister energy as in the methods of the embodiment.

Such a bed or pod design can be adapted for use in the methods of theembodiments by substituting one or more emitters as described herein forconventional UV lamps. The emitters can be of the same or differenttype, and configured to deliver the same or different energy (RF, heat,light, microwave, or ultrasonic). When multiple emitters are employed,they can be arranged in any suitable configuration, e.g., an array of 2or more emitters, e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10 to 11, 12, 13, 14,15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50,55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160,170, 180, 190, or 200 emitters. The emitters can be arrayed in a grid(e.g., square, triangular, offset rows, random) and can be individuallyactuated to deliver a desired radiation profile (wavelength, frequency,total energy delivered, power, continuous, intermittent, or any otherdesired variation) to targeted areas of the patient's body. The emitterscan be stationary, or can be configured to be movable within the deviceso as to provide a desired energy profile to the patient. In anembodiment employing one emitter, it can be desirable to employ amoveable emitter. Such a moveable emitter can be one that moves in afixed path along a track in the device, or can be incorporated into arobotic positioning system configured to move the emitter in threedimensions over the patient's body.

The bed can be further equipped with one or more thermal cameras orvisible wavelength cameras. The one or more cameras can be positioned inthe bed or pod so as to provide coverage of portions of the patient'sbody, or the entirety of the patient's body. Advantageously, the camerascan be integrated into the bed or pod between the emitters. Images fromone or more of the cameras, e.g., a thermal camera or visible lightcamera, can be processed, e.g., by a microprocessor or other computerimplementing pattern recognition software as part of the overalltreatment system, to determine the positioning, size, shape, andtopography of the patient. This information can be used to generate a3-dimensional construct that can be employed by the system to select thedesired operating parameters of the emitters adjacent to the area(s) ofthe patient's body to be treated, e.g., while treatment is in progress,so as to account for movement of the patient, or to deactivate emittersthat are not positioned over a portion of the patient due to thepatient's positioning or size. The thermal cameras can also be employedto provide feedback regarding patient temperature at various locationswhich can be employed to adjust emitter operating conditions, e.g., toincrease, decrease, start, stop, or otherwise adjust some aspect of theenergy being delivered to the patient.

In certain embodiments, it may be desirable to immobilize the patientduring treatment. Suitable apparatus can be provided, as is employed inother imaging technologies, so as to position and/or immobilize one ormore areas of the body to be treated, e.g., frames, clamps, bindings,etc.

The treatment system can include a microprocessor or other computerbuilt into the bed or pod to perform one or more of the computingfunctions described herein, or a microprocessor or other computer can beconnected via a wired connection or wirelessly to the bed to controlprocesses. A single processing system can be employed, or a plurality ofprocessing systems can be employed that perform different tasks.

In one embodiment, a system utilizing a pod, bed, or booth is configuredto provide an assessment of a patient's fat. Cameras can be employed tocreate a three-dimensional construct of the patient that can be analyzedto determine fat-bearing areas to be targeted for treatment. The systemthen uses this information to determine a treatment protocol. Thetreatment is administered, with adjustments to the treatment protocolmade using feedback from one or more sensors, e.g., thermal imagingcameras that detects the extent to which fat is burned. When a desireddegree of fat burning is detected, then the treatment is ended. The oneor more cameras can also be employed to determine positioning of thepatient, e.g., to compensate for movement. The system can advantageouslyemploy one or more motors and associated systems that move the one ormore transmitters (and/or one or more cameras or sensors) around thepatient, e.g., while assessing fat. The moving parts of the system canadvantageously be placed such that they do not contact the patient'sbody, e.g., behind a transmissive structure, e.g., a polymer window, apolymer or metal grid, or other structure.

FIGS. 10-12 provide images of commercial tanning beds. A similarconfiguration can be adapted for use with the transmitters of preferredembodiments.

While this invention has been described in connection with what arepresently considered to be practical embodiments, it will be appreciatedby those skilled in the art that various modifications and changes maybe made without departing from the scope of the present disclosure. Itwill also be appreciated by those of skill in the art that parts mixedwith one embodiment are interchangeable with other embodiments; one ormore parts from a depicted embodiment can be included with otherdepicted embodiments in any combination. For example, any of the variouscomponents described herein and/or depicted in the Figures may becombined, interchanged, or excluded from other embodiments. With respectto the use of substantially any plural and/or singular terms herein,those having skill in the art can translate from the plural to thesingular and/or from the singular to the plural as is appropriate to thecontext and/or application. The various singular/plural permutations maybe expressly set forth herein for sake of clarity. Thus, while thepresent disclosure has described certain exemplary embodiments, it is tobe understood that the invention is not limited to the disclosedembodiments, but, on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the scope ofthe appended claims, and equivalents thereof.

Embodiments of the present disclosure are described above and below withreference to flowchart illustrations of methods, apparatus, and computerprogram products. It will be understood that each block of the flowchartillustrations, and combinations of blocks in the flowchartillustrations, can be implemented by execution of computer programinstructions. These computer program instructions may be loaded onto acomputer or other programmable data processing apparatus (such as acontroller, microcontroller, microprocessor or the like) in a sensorelectronics system to produce a machine, such that the instructionswhich execute on the computer or other programmable data processingapparatus create instructions for implementing the functions specifiedin the flowchart block or blocks. These computer program instructionsmay also be stored in a computer-readable memory that can direct acomputer or other programmable data processing apparatus to function ina particular manner, such that the instructions stored in thecomputer-readable memory produce an article of manufacture includinginstructions which implement the function specified in the flowchartblock or blocks. The computer program instructions may also be loadedonto a computer or other programmable data processing apparatus to causea series of operational steps to be performed on the computer or otherprogrammable apparatus to produce a computer implemented process suchthat the instructions which execute on the computer or otherprogrammable apparatus provide steps for implementing the functionsspecified in the flowchart block or blocks presented herein.

It should be appreciated that all methods and processes disclosed hereinmay be used in any thermal treatment system. It should further beappreciated that the implementation and/or execution of all methods andprocesses may be performed by any suitable devices or systems, whetherlocal or remote. Further, any combination of devices or systems may beused to implement the present methods and processes.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive. Thedisclosure is not limited to the disclosed embodiments. Variations tothe disclosed embodiments can be understood and effected by thoseskilled in the art in practicing the claimed disclosure, from a study ofthe drawings, the disclosure, and the appended claims.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein. It should benoted that the use of particular terminology when describing certainfeatures or aspects of the disclosure should not be taken to imply thatthe terminology is being re-defined herein to be restricted to includeany specific characteristics of the features or aspects of thedisclosure with which that terminology is associated. Terms and phrasesused in this application, and variations thereof, especially in theappended claims, unless otherwise expressly stated, should be construedas open ended as opposed to limiting. As examples of the foregoing, theterm ‘including’ should be read to mean ‘including, without limitation,’‘including but not limited to,’ or the like; the term ‘comprising’ asused herein is synonymous with ‘including,’ ‘containing,’ or‘characterized by,’ and is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps; the term ‘having’ shouldbe interpreted as ‘having at least;’ the term ‘includes’ should beinterpreted as ‘includes but is not limited to;’ the term ‘example’ isused to provide exemplary instances of the item in discussion, not anexhaustive or limiting list thereof; adjectives such as ‘known’,‘normal’, ‘standard’, and terms of similar meaning should not beconstrued as limiting the item described to a given time period or to anitem available as of a given time, but instead should be read toencompass known, normal, or standard technologies that may be availableor known now or at any time in the future; and use of terms like‘preferably,’ ‘preferred,’ ‘desired,’ or ‘desirable,’ and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the invention, but instead as merely intended to highlightalternative or additional features that may or may not be utilized in aparticular embodiment of the invention. Likewise, a group of itemslinked with the conjunction ‘and’ should not be read as requiring thateach and every one of those items be present in the grouping, but rathershould be read as ‘and/or’ unless expressly stated otherwise. Similarly,a group of items linked with the conjunction ‘or’ should not be read asrequiring mutual exclusivity among that group, but rather should be readas ‘and/or’ unless expressly stated otherwise.

Where a range of values is provided, it is understood that the upper andlower limit, and each intervening value between the upper and lowerlimit of the range is encompassed within the embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity. The indefinite article “a” or “an” does not exclude aplurality. A single processor or other unit may fulfill the functions ofseveral items recited in the claims. The mere fact that certain measuresare recited in mutually different dependent claims does not indicatethat a combination of these measures cannot be used to advantage. Anyreference signs in the claims should not be construed as limiting thescope.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of theinvention to the specific embodiments and examples described herein, butrather to also cover all modification and alternatives coming with thetrue scope and spirit of the invention.

What is claimed is:
 1. A method for applying thermal treatment,comprising: providing a target site on a patient, the target sitecomprising tissue having certain characteristics; positioning a thermaltransmitter, the thermal transmitter configured to transmit thermalenergy toward the target site; applying the thermal energy to the targetsite according to a thermal treatment routine, the thermal energy havinga selected frequency or wavelength, a selected power level, and adirection; capturing thermal data and thermal images of the target sitewith a thermal imager, the thermal data and thermal images correspondingto a tissue temperature at the target site; and displaying the thermaldata and the thermal image of the target site on a thermal display. 2.The method of claim 1, further comprising: selecting the thermaltreatment routine according to the characteristics; monitoring thethermal images and the thermal data for an optimum tissue temperature;and adjusting the selected frequency or wavelength, the selected powerlevel, or the direction, according to the monitoring and the selectedroutine.
 3. The method of claim 1, further comprising applying thethermal energy to the tissue at the target site at a selected depthanywhere in the range of zero to 15,000 micrometers below the surface ofthe skin at the target site.
 4. The method of claims 1, furthercomprising storing information related to the execution of the selectedroutine in a memory accessible by the processor, the thermaltransmitter, and the thermal imager, the memory further comprising atleast one database for storing a plurality of routines.
 5. The method ofclaim 1, further comprising: wirelessly communicating the thermal dataand the thermal images from the thermal imager to the thermal display;and wirelessly communicating a plurality of control signals from acontroller to the thermal transmitter and the thermal imager.
 6. Themethod of claim 1, further comprising displaying the thermal data andthe thermal images on a gradient map, the gradient map configured todepict a plurality of temperatures of the tissue at the target site thea selected depth beneath the surface of the skin.
 7. The method of claim1, the thermal imager configured to provide thermal data at a positionwithin the tissue anywhere in a range from a surface of the skin to15,000 micrometers below the surface of the skin.
 8. The method of claim1, the thermal transmitter being configured to transmit thermal energyto a selected depth anywhere in a range from a surface of the skin to15,000 micrometers below the surface of the skin at the target site. 9.The method of claims 1, the thermal transmitter further configured toheat the tissue at the target site to a temperature anywhere in a rangeof from 35 degrees Celsius to 50 degrees Celsius.
 10. The method ofclaims 1, the thermal transmitter further configured to cryogenicallycool the tissue at the target site to a temperature anywhere in a rangeof from 10 degrees Celsius to negative 20 degrees Celsius.
 11. Themethod of claims 1, wherein the thermal display is configured to displayat least one of the thermal images, the thermal data, and the gradientmap, the gradient map indicating graphical depiction of the temperaturesof the tissue at the target site at the selected depth.